CannPal Animal Therapeutics (ASX: CP1) has secured its import licence from the Australian Government’s Office of Drug Control, which will allow it to bring cannabis formulations into the country for research on its CPAT-01 drug.
The cannabis formulations will be imported under an existing memorandum of understanding with Canada-based Aphria Inc (TSX: APH), which will supply cannabis oils for the CPAT-01 drug research.
“The granting of this import licence is a significant step for CannPal in our goal towards becoming a market leader in cannabinoid-derived animal therapeutics,” CannPal founder and managing director Layton Mills said.
“It’s a major milestone that will allow us to import medicinal cannabis, so we can begin the clinical phase of our research,” Mr Mills added.
This latest approval comes after the New South Wales Department of Health granted an application for CannPal to possess and supply cannabidiol (CBD) and tetrahydrocannabinol (THC).
Cannpal also received ethics approvals in late October to kick-off its first two phases of the study into the safety and tolerability of CPAT-01.
The import licence was one of the final hurdles for CannPal in obtaining regulatory permission to start phase one of its CPAT-01 clinical trial, which is scheduled to start in the first three months of next year.
Pharmacokinetic and safety clinical trials will involve studying 48 dogs for safety, tolerability and clinical observations using THC and CBD. The second phase is due to conclude by mid-2018, with a third and final phase to begin soon after.
Veterinary research organisation Invetus Ltd is working with CannPal on the clinical trial and will be storing CannPal’s cannabis-based oil as well as undertaking the study.
Additionally, the University of Queensland’s TetraQ Research Infrastructure Centre will be providing the bioanalytical services for the trials. The bioanalytical services will comprise measuring CBD and THC levels in the animals’ plasma samples.
According to CannPal, its CPAT-01 drug can offer pain relief to dogs and other animals without the side-effects of current treatments.
CannPal estimates the global non-steroidal, anti-inflammatory drug market is worth A$1.4 billion.